Pluri signed a deal worth $4.2 million with the US National Institute of Allergy and Infectious Diseases (NIAID), a division of NIH, in 2023. $1.4 million of the total amount has been dedicated by NIH to Pluri’s PLX-R18, a medical countermeasure for exposure to nuclear radiation or H-ARS.
“In the second year of the NIAID contract for PLX-R18 development, Pluri plans to extend the mechanism of recovery with focus on items that will be important to gain the US Food and Drug Administration (FDA) approval including strong understanding the treatment's effectiveness and safety,” a spokesperson for the firm told BioProcess Insider.
“A significant focus will be [...] to determine optimal dosages that maximize therapeutic benefits while minimizing risks. These studies will include survival analysis to assess the impact on life expectancy post-treatment. Successful accomplishment of all planned studies will enable further advancement of PLX-R18 development.”
In the initial contract year, Pluri met its research and development goals for PLX-R18 against radiation-related blood complications. The firm mass-produced, setting the stage for the drug's availability upon approval.
According to the firm, PLX-R18 boosts all three blood cell types—white, red, and platelets—unlike other treatments that focus on one lineage, often with side effects. It is safe and well-tolerated, even in healthy individuals, which is crucial in scenarios such as a mass catastrophe event following radiation exposure, when monitoring and identifying specific individuals is not possible.
“PLX-R18 has the potential to become a first in class, allogeneic, off the shelf cell therapy for comprehensive hematological deficiencies. We are developing PLX-R18 for acute radiation syndrome (ARS) and other hematological deficiencies,” the spokesperson added.
“In light of recent geopolitical events and the global threat of nuclear disasters, we believe it is crucial to advance development of innovative treatments for the devastating symptoms that follow radiation exposure. Moreover, nuclear energy is referred to as a clean energy technology as it produces nearly zero carbon dioxide or other greenhouse gas emissions and avoids producing air pollutants that are often associated with burning fossil fuels for energy.”
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